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Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis

This study is currently recruiting participants.
Verified November 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Xueding Wang, University of Michigan
ClinicalTrials.gov Identifier:
NCT00748254
First received: September 4, 2008
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this feasibility study is to determine if a new emerging technology called photoacoustic tomography (PAT) can be adapted for use in humans for the detection of chronic rheumatoid arthritis.


Condition Intervention Phase
Arthritis, Rheumatoid
 Procedure: Laser Based Photoacoustic Tomography, MRI, Ultrasound
Procedure: laser based photoacoustic tomography, MRI, ultrasound
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Photoacoustic Imaging [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To determine if photoacoustic imaging (PAT) can accurately assist in the diagnosis of chronic rheumatoid arthritis


Estimated Enrollment: 120
Study Start Date: February 2008
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rheumatoid Arthritis
Active disease
 Procedure: Laser Based Photoacoustic Tomography, MRI, Ultrasound
Tomography, MRI, and ultrasound of both hands
Other Names:
  • MRI,magnetic resonance imaging
  • US, ultrasound
  • PAT, laser based photoacoustic tomography
Active Comparator: Normal controls
Healthy volunteers
 Procedure: laser based photoacoustic tomography, MRI, ultrasound
laser based photoacoustic tomography, MRI, and ultrasound of both hands
Other Names:
  • laser based photoacoustic tomography
  • MRI
  • Ultrasound

Detailed Description:

The objective of this proposal is to adapt photoacoustic tomography (PAT), a novel, nonionizing, noninvasive, laser-based technology, for structural and functional imaging of human peripheral joints affected by inflammatory arthritis. Combining the merits of light and ultrasound, PAT holds promise to present objective optical information in subsurface joint tissues with high sensitivity and high spatial resolution, which could be of considerable help in the early detection of inflammatory joint diseases. PAT may also prove useful in further understanding the pathophysiology of these disorders and assisting with therapeutic decisions, including assessment of new pharmacological therapies.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women 18 years of age through age 60 can participate in this study.
  • Patients can participate in this study if they have had rheumatoid arthritis for more than 2 years and their rheumatologist has referred them to this study.
  • Patients can participate as a healthy volunteer with a known history of rheumatoid arthritis.

Exclusion Criteria:

  • Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
  • Pregnant patients.
  • Patients who is claustrophobic.
  • Patients with impaired renal function cannot participate in this study such as elevate creatinine clearance, patients on kidney dialysis etc.
  • Patients with shock hypotension or unstable low blood pressure.
  • Patients with Rhabdomyolysis.
  • Patients who have had a contrast enhanced (with gadolinium) MRA/MRI within the last 3 months. (Contrast is a medication injected into a vein during a imaging examination that helps produce clearer images/pictures).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748254

Contacts
Contact: Xueding Wang, PhD 734 647-2728 xdwang@umich.edu

Locations
United States, Michigan
Universtity of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Xueding Wang, PHD            
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Xueding Wang, Ph.D University of Michigan
  More Information

No publications provided

Responsible Party: Xueding Wang, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00748254     History of Changes
Other Study ID Numbers: HUM00003693
Study First Received: September 4, 2008
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013